News

29.08.2022

The 11th Ukrainian forum of medical device market operators was held

On August 26, the 11th anniversary Ukrainian forum of medical device market operators took place, which provided manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience during martial law. Ukrainian Scientific Institute of Certification was traditionally a partner of this event. In addition, Victoria Shevchenko, Head […]

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22.08.2022

Features of medical device conformity assessment in wartime with or without conformity assessment body involvement

The Ukrainian Scientific Institute of Certification invites you to take part in the 11th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]

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12.08.2022

Changes in the medical device regulation in Ukraine

In connection with the establishment of conformity assessment processes and the possibility of carrying out works that ensure the availability of the necessary products on the Ukrainian market with confirmed safety and efficiency, on August 9, 2022, the Ministry of Health withdrew the letter dated February 25, 2022 No. 24-04/5396/2-22 allowing the placing of the […]

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27.07.2022

The entry into force of the Technical Regulations for cosmetic products has been postponed for 2 years

On July 26, 2022, the Cabinet of Ministers of Ukraine adopted a resolution “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine dated January 20, 2021 No. 65” in order to postpone the date of entry into force of the Technical Regulations for cosmetic products and introduce a transitional period in this […]

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08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

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30.05.2022

The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

On May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC. The seminar showed the great […]

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